Supplier Quality Specialist – Audits & Compliance

Masis Professional Group; North Carolina; On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Fully furnished temporary housing

Relocation stipend

Area exploration visits

Weekly pay

Christmas shutdown

Annual tuition reimbursement

Gym reimbursement

Company-paid life insurance

Company-paid short-term disability

Employee Assistance Program (EAP)

Annual HSA contribution

Job summary

Masis Professional Group seeks a Supplier Quality Specialist – Audits & Compliance in the Charlotte, NC area. You will develop and maintain a robust internal compliance program and lead internal and external audits to ensure FDA-regulated quality and regulatory alignment.

The ideal candidate has 5+ years in QA auditing in cGMP environments with vendor/supplier auditing, experience with 21 CFR Parts 210, 211 and 21 CFR 111, and proficiency with SAP and MS Office.

Qualifications

• Minimum 5 years QA auditing in a cGMP environment and 5 years external supplier auditing in FDA-regulated industry.
• Experience with 21 CFR Parts 210, 211 and 21 CFR 111.
• ASQ Certified Auditor (CQA) preferred.
• Proficient in MS Office applications.
• Travel 20–30% for domestic audits; international travel may be needed.
• Plan, schedule, and conduct internal and external audits for regulatory and quality compliance.
• Audit suppliers and CMOs and maintain vendor qualification programs.
• Manage SCARs and verify CAPA implementation.
• Assess findings, determine risk levels, and drive corrective actions.
• Maintain audit, supplier, and compliance documentation in QMS.
• Monitor and report audit/compliance metrics to management.
• Train cross-functional teams on quality/compliance.
• Identify compliance risks and support process improvements.
• Support regulatory inspection readiness and ongoing compliance initiatives.
• Utilize SAP and electronic quality systems to support QA activities.

Responsibilities

• Develop and maintain an Internal Compliance program.
• Perform internal and external audits to ensure regulatory and quality compliance.
• Audit suppliers and CMOs and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify CAPA implementation.
• Monitor and report audit and compliance metrics to management.
• Train cross-functional teams on quality and compliance requirements.
• Identify compliance risks and support process improvements to mitigate risk.
• Support regulatory inspection readiness and ongoing compliance initiatives.

Skills

Quality Auditing

External Audits

CGMP

FDA Regulated

MS Office

SAP

Travel 20-30%

Internal Audits

Vendor Qualification

CAPA

Education

ASQ Certified Auditor (CQA)

Tools

SAP

Electronic Quality Systems

Job description

Supplier Quality Specialist – Audits & Compliance

30-45 minutes of Charlotte, NC

$85k-$95k + discretionary bonus potential up to 12% of YTD earnings

US Citizens or Green Card Holders only | No C2C

Join an industry-leading health and wellness manufacturer dedicated to improving lives through science, innovation, and uncompromising quality. With a strong reputation for excellence, the company develops trusted products backed by research and produced to the highest standards of quality and compliance.

Employees enjoy a collaborative, values-driven culture that emphasizes integrity, continuous improvement, professional growth, and making a meaningful impact every day. If you're looking to join a mission-focused organization where quality matters and people are valued, you'll feel right at home here!

The Supplier Quality Specialist – Audits & Compliance reports to the Supplier Quality and Compliance Manager. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The Supplier Quality Specialist is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.

• Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.
• Experience with 21 CFR Parts 210, 211 and 21 CFR 111
• ASQ Certified Auditor (CQA) Certification is preferred.
• Must be proficient in Computer Software applications including MS office suite.
• Must be able to travel 20 – 30% for domestic audits, (International travel may be needed per quality management).
• Plan, schedule, and conduct internal and external audits to ensure regulatory and quality compliance.
• Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify effective CAPA implementation.
• Assess audit findings, determine risk levels, and drive corrective and preventive actions.
• Maintain audit, supplier, and compliance documentation within the Quality Management System (QMS).
• Monitor and report audit and compliance metrics to management.
• Train and support cross-functional teams on quality and compliance requirements.
• Identify compliance risks and support process improvements to mitigate risk.
• Support regulatory inspection readiness and ongoing compliance initiatives.
• Utilize SAP and electronic quality systems to support Quality Assurance activities.

Preferred:

SAP and Quality Management System experience

• 45 Days of Fully Furnished Temporary Housing
• $5,000 Relocation Stipend
• Paid Area Exploration Visits
• Weekly Pay
• Christmas Eve-New Year's Shutdown
• Up to $5,000 Annual Tuition Reimbursement
• Gym/Fitness Reimbursement
• Company-Paid Life Insurance
• Company-Paid Short-Term DisabilityEmployee Assistance Program (EAP)
• Annual HSA Contribution

A company that truly invests in its employees and their families!